Director, QA GMP Operations
Dyne TherapeuticsWaltham, Massachusetts, United States · Posted 8 months agoDescription
Company Overview:
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance. The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview.
This is an onsite role based in Waltham, MA.
Primary Responsibilities Include:
- Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities.
- Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines.
- Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs.
- QA support of Tech Transfer and Process Validation activities.
- Disposition of GMP batches and interfacing with the Qualified Person (QP).
- Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts.
- Manage CDMO performance within Quality Agreement expectations and GMP compliance.
- Drive continuous improvement and inspection readiness.
- Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally.
- Adjudicate on compliance discussions and negotiate any required corrective actions.
- Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence.
Education and Skills Requirements:
- Minimum of a BA/BS degree
- Minimum of 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company
- Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
- Experience implementing and utilizing various outsourcing and support models
Similar jobs
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 115,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 140,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 120,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medic…
Est. 120,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 120,000 USD
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases.…
Est. 105,000 USD
About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trus…
Est. 85,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 85,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 140,000 USD
The Role The Director, Technology Applications provides strategic and tactical leadership and works in collaboration with the IT Leadership team and Business Partners to deliver integrated technology solutions. From an A…
Est. 80,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 85,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 65,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 120,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 120,000 USD
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop diffe…